BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 3063459 · Received March 28, 2013

    Report

    Report Number
    1219930-2013-00165
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 27, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE NEEDLE WOULD NOT COME OUT OF THE DEVICE AND LATCH. THE NEEDLE WAS STILL IN THE DEVICE AND JAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127355 ENDO STITCH 10MM SUTURING DEVICE SURGICAL SUTURING DEVICE KOG COVIDIEN, FORMERLY US SURGICAL N2L0425X

    Patients

    Seq Age Sex Outcome Treatment
    1